MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW PLUS; HYSTEROSCOPE 30° Ø 3.9MM WL 217MM RIGID

Model Number 8986402

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf (b)(4).Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr/complaint open.Rwmic will contact the user facility for missing patient information.Rwmic will submit a follow up report with additional information and investigation of the complaint.

Event Description

On november 4th, 2020, the user facility reported the following to richard wolf medical instruments corporation (rwmic): while using the scope flecks of metal were coming off into the patients body.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? no.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? no.Did the delay put the patient at risk? (only applicable if there was a report of delay) no.Was there a similar back-up device available for use? unknown.Was the scheduled procedure completed? yes.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.The following sections include new or changed information: b4, b5 g3, g6, h2, h3, h6, and h10.Labeling review (ga-e200) & (ga-1020): caution: the products have only limited strength! exerting excessive force will cause damage, impair the function and thus endanger the patient.Immediately before and after each use, check the products for damage, loose parts and completeness.Ensure that no missing instrument parts remain in the patient.Do not use products which are damaged, incomplete or have loose parts.Caution: if products are damaged or incomplete, possible injury of patient, user or third person run through the checks before and after each use do not use products which are damaged or incomplete or have loose parts, return damaged products together with loose parts for repair, do not attempt to do any repairs yourself.Rwmic will contact the user facility for missing patient information.A follow up report will be submitted after additional information become available.

Event Description

Device evaluation (b)(6) 2021.Findings: according to our test instruction 8986402 pa we found: a) the distal part ofthe cladding tube is heavily crushed and bent up.Lt is highly probable that a piece has come loose at the edge ofthe distal cladding tube.B) the cladding tube is bent.C) distal light end surface is overheated and porous.A, b) the hysteroscope gets damaged by mechanical intluences/ overload (customer fault).C) the cause of damage is due to insufficient cleaning and care of the distal light-emitting surface.The user is informed in the ifu ga-e200 chapter 7.2 and in the applicable ga-1020 to clean the glass light-emitting surfaces with a cotton swab soaked in alcohol, as this considerably worsens the light transmission.The device does not meet the specifications and the reported conditions were confirmed during device evaluation.

• Brand Name: PANOVIEW PLUS
• Type of Device: HYSTEROSCOPE 30° Ø 3.9MM WL 217MM RIGID
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10818075
• MDR Text Key: 234319503
• Report Number: 1418479-2020-00044
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04055207023686
• UDI-Public: 04055207023686
• Combination Product (y/n): N
• PMA/PMN Number: K880314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8986402
• Device Catalogue Number: 8986402
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1